The World Health Organization (WHO) has announced that its next phase in its Solidarity trial, Solidarity PLUS, will enroll hospitalized patients to test three new drugs in hospitalized COVID-19 patients in 52 countries.
According to the WHO, these therapies – artesunate, imatinib and infliximab – were selected by an independent expert panel for their potential in reducing the risk of death in hospitalized COVID-19 patients after the drugs were donated for the trial by their manufacturers.
Meanwhile, the drugs are already used for other indications: artesunate is used for severe malaria, imatinib for certain cancers, and infliximab for diseases of the immune system such as Crohn’s Disease and rheumatoid arthritis.
“Finding more effective and accessible therapeutics for COVID-19 patients remains a critical need, and WHO is proud to lead this global effort. I would like to thank the participating governments, pharmaceutical companies, hospitals, clinicians and patients, who have come together to do this in true global solidarity” .
Dr. Tedros Adhanom Ghebreyesus, WHO Director-General
The Solidarity PLUS trial
WHO highlighted that the Solidarity PLUS trial is a platform trial that represents the largest global collaboration among WHO Member States. It involves thousands of researchers in over 600 hospitals in 52 countries, 16 more countries than the first phase of trials, the WHO said.
The aim, according to the WHO, is to allow the trial to assess multiple treatments at the same time using a single protocol, recruiting thousands of patients to generate robust estimates on the effect a drug may have on mortality, even moderate effects.
Moreover, the trial allows new treatments to be added and ineffective treatments to be dropped throughout the course of the trial.
Previously, four drugs were evaluated by the trial. The results showed that remdesivir, hydroxychloroquine, lopinavir and interferon had little or no effect on hospitalized patients with COVID-19. Meanwhile, the WHO noted that through the Solidarity PLUS trial, researchers across the world have an opportunity to use their expertise and resources to contribute to global COVID-19 research.
Details on the selected drugs
The Organization further gave explicit details on the three drugs selected for the new trial. The WHO noted that Artesunate, produced by Ipca and used to treat malaria, will be administered intravenously for 7 days, using the standard dose recommended for the treatment of severe malaria as part of the trial.
Also, Imatinib, produced by Novartis, will be administered orally, once daily, for 14 days with the standard maintenance dose, which is at the lower end of the dose patients with haematological malignancies are given over extended periods. A randomized clinical trial performed in the Netherlands reported that imatinib might confer clinical benefit in hospitalized COVID-19 patients, in the absence of safety issues.
Infliximab
Produced by Johnson and Johnson, Infliximab will be administered intravenously as a single dose in the trail. The dose used is the standard dose that patients with Crohn’s Disease are given over extended periods.
Infliximab is a TNF alpha inhibitor, a chimeric monoclonal antibody that recognizes human TNF alpha. Anti-TNF biologics have been approved for treatment of certain autoimmune inflammatory conditions for more than 20 years, demonstrating favourable efficacy and safety in restricting broad spectrum inflammation, including in elderly populations who are most clinically vulnerable to COVID-19.
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